Novartis Conducts Fluvirin Recovery

November 3, 2006
Pharmaceutical Technology Editors

ePT--the Electronic Newsletter of Pharmaceutical Technology

Liverpool, UK (Oct. 20)-Novartis Vaccines and Diagnostics Limited is recovering two lots totaling 500,000 doses of its ?Fluvirin? influenza virus vaccine after reports that the product had been received from distributor Cardinal Health Care in either a frozen state or below the required storage temperature range of 35?46 degrees F.

Liverpool, UK (Oct. 20)-Novartis Vaccines and Diagnostics Limited (www.novartis.com) is recovering two lots totaling 500,000 doses of its “Fluvirin” influenza virus vaccine after reports that the product had been received from distributor Cardinal Health Care (LaVergne, TN, www.cardinalhealth.com) in either a frozen state or below the required storage temperature range of 35­–46 degrees F.

The 5-mL multidose vials containing the “Chiron Vaccines” label have lot numbers 71209 and 71210 (both with an expiration date of June 30, 2007). They were shipped under a contract with the Centers for Disease Control and distributed between Oct. 11 and Oct. 17, 2006. Novartis is conducting the recovery solely as a precautionary action. Freezing inactivates the influenza vaccine but its administration does not pose a risk to patient safety, according the Recovery Notice posted by the US Food and Drug Administration (Rockville, MD, www.fda.gov). Meanwhile, Cardinal Health is reportedly conducting its own investigation into how the product became frozen.

Novartis plans to ship new vaccines through a different distributor in early November.